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Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization

NCT07187804 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-23

No results posted yet for this study

Summary

Type 3 macular neovascularization (MNV) is a subtype of neovascular age-related macular degeneration accounting for 10-20% of cases, notable for high rates of bilateral involvement and risk of profound vision loss, particularly if undertreated. Early and proactive therapy is crucial to prevent progression and preserve vision.

Faricimab offers potential advantages in this setting. Eyes with type 3 MNV often show thin choroid, reticular pseudodrusen, and high GA risk, reflecting compromised choroidal perfusion. While anti-vascular endothelial growth factor (VEGF) agents suppress neovascularization, prolonged VEGF blockade may impair choriocapillaris health. Ang-2 inhibition, by promoting Tie2 activation and vascular stability, may protect choriocapillaris and reduce widespread retinal edema and hemorrhages observed in type 3 MNV.

Finally, while treat-and-extend is widely used in practice, existing trials (TENAYA, LUCERNE) applied broader extension intervals than typically used clinically. In type 3 MNV, where undertreatment carries severe consequences, a more stringent faricimab-based treat-and-extend regimen with 2-week interval adjustments warrants investigation.

Conditions

  • Age-related Macular Degeneration (ARMD)
  • Choroidal Neovascularization
  • Anti-vascular Endothelial Growth Factor

Interventions

DRUG

Intravitreal faricimab injection

* Initial loading injections : every 4 weeks by 12weeks * Treat and extend injection(\~76 week) : Week 20 - Week 76 TAE is initiated with a minimum injection interval of 8 weeks. If no recurrence is observed, the interval is extended by 2 weeks at a time, up to a maximum of 16 weeks. In the event of recurrence, the injection interval is reduced to 8 weeks, regardless of the previous schedule. The minimum injection interval remains 8 weeks.

Sponsors & Collaborators

  • Kim's Eye Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2028-09-22
Completion
2028-09-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187804 on ClinicalTrials.gov